Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 2221–2240 of 38,428 recalls
Recalled Item: Alcon Laboratories
The Issue: Due to the potential that some units within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Laboratories
The Issue: Due to the potential that some units within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Laboratories
The Issue: Due to the potential that some units within
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage PureFlow-B Solution. Catalog numbers: RFP-400
The Issue: for the perimeter seal on the small
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m Resp-4-Plex AMP Kit
The Issue: There were reports of an increase in reactive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity m Resp-4-Plex Amplification (AMP) Kit (CE)
The Issue: There were reports of an increase in reactive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AcoSound. Model Number: LW12-BTE-M
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tecfen Medical Product Name: 3.2mm Slit Knife
The Issue: Sterility assurance for Ophthalmic knives
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tecfen Medical Product Name: 2.0mm Crescent Knife Angled
The Issue: Sterility assurance for Ophthalmic knives
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tecfen Medical Product Name: 15 degree Stab Knife
The Issue: Sterility assurance for Ophthalmic knives
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tecfen Medical Product Name: 2.8mm Slit Knife
The Issue: Sterility assurance for Ophthalmic knives
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MUSE 5 Systems
The Issue: The MUSE Administrator Account active directory or local
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tecfen Medical Product Name: 20G (1.2mm) MVR Sideport
The Issue: Sterility assurance for Ophthalmic knives
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tecfen Medical Product Name: 2.2mm Slit Knife
The Issue: Sterility assurance for Ophthalmic knives
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tecfen Medical Product Name: 2.4mm Slit Knife
The Issue: Sterility assurance for Ophthalmic knives
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iBOT PMD with software version 01.05.24. Personal Mobility Device.
The Issue: Software issue that could potentially lead to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
The Issue: transit delays of certain cold chain products due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.